CHILDHOOD AGRICULTURAL SAFETY AND HEALTH RESEARCH
RELEASE DATE: March 20, 2003
RFA: OH-03-003 (This RFA has been modified, see RFA-OH-07-002)
LETTER OF INTENT RECEIPT DATE: April 18, 2003
APPLICATION RECEIPT DATE: May 23, 2003
National Institute for Occupational Safety and Health, (NIOSH), Centers for
Disease Control and Prevention (CDC), Department of Health and Human Services
(http://www.cdc.gov/niosh/homepage.html)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.956
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the RFA
o Research Objectives
o Mechanism(s)of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The Centers for Disease Control and Prevention (CDC), National Institute for
Occupational Safety and Health (NIOSH) announces the availability of fiscal
year (FY) 2003 funds for grant applications for research on childhood
agricultural safety and health. Projects are sought which will conduct
research to: (1) develop and evaluate new or existing enhanced control
technologies to reduce injury to youth exposed to farm hazards, (2) develop
and evaluate incentives which encourage adults to protect youth from farm
hazards, or (3) identify the economic and social consequences of youth
working on farms. Findings from these projects are intended to advance the
scientific base of knowledge needed to maximize the safety and health of
children exposed to agricultural production hazards.
This announcement identifies program needs consistent with the National
Occupational Research Agenda (NORA) developed by NIOSH and partners in the
public and private sectors to provide a framework to guide occupational
safety and health research in the new millennium towards topics which are
most pressing and most likely to yield gains to the worker and the nation.
The agenda identifies 21 research priorities. NORA priorities with specific
relevance to this announcement are: traumatic injuries, special populations
at risk, intervention effectiveness research, and social and economic
consequences of workplace illness and injury. Information about NORA is
available through the NIOSH Home Page; http://www.cdc.gov/niosh/nora/.
RESEARCH OBJECTIVES
Background
Agricultural production, which commonly encompasses farming, consistently
ranks among the industries with the highest rates of work-related injuries
and deaths in the United States and is unique with respect to children and
adolescents. This is the only industry in which the workplace is often also a
home. Youth, children and adolescents, who commonly work on farms are exposed
to agricultural production hazards. However, exposures to agricultural
hazards are not only experienced by working youths, non-working children who
live on or visit farms may also be exposed to farm hazards. Research is
needed to expand the knowledge base for the development and implementation of
effective and appropriate intervention strategies.
Surveillance activities by NIOSH over the past four years indicate an
estimated 32,800 agriculture-related injuries occurred nationally to children
or adolescents under the age of 20 who lived on, worked on, or visited a
farm. Forty-four percent or about 15,000 of these injuries were work-
related, and 70% of the work injuries were incurred by youth who live on the
farm. In fact, youth who live on farms incurred about 72% of all injuries
which happen to youth on farms. Fatality surveillance indicates over 100
deaths occur to youth 19 years of age and younger on farms. About 33% of the
farm deaths occur to youth 15-19 years of age and males account for 85% of
all farm deaths. Nearly 40% of the deaths among males occur between the ages
of 15 and 19, while about 40% of the deaths among females happen before the
age of five. Two regions of the United States, the South and the Midwest,
accounted for 79% of all fatal farm injuries. Farm tractors, farm machinery,
stored grain, power lines, manure pits, ponds, and livestock are among the
many hazards youth are exposed to in the agricultural workplaces. Children
and adolescents may be exposed to agricultural production hazards not only
through work activities, but by virtue of living on a farm, accompanying
their parents to work, or visiting farms.
Goals
The goals of childhood agricultural safety and health research grants are to
maximize the safety and health of children and adolescents exposed to
agricultural hazards through the prioritization, development, or
implementation of intervention efforts. Projects are sought in one of three
research areas which have been identified as priority areas in the documents
Children and Agriculture: Opportunities for Safety and Health: A National
Action Plan http://research.marshfieldclinic.org/children/action/title.htm
or the Childhood Agricultural Injury Prevention: Progress Report and Updated
National Action Plan from the 2001 Summit
http://www.marshfieldclinic.org/research/children/childrensReport/
and provided below:
o Develop and Evaluate New or Existing Enhanced Control Technologies.
Control technologies, in the broadest sense, include any strategy which will
control the exposure of children to agricultural hazards. Exposures to
agricultural hazards may be reduced through engineering controls and/or
administrative controls. Examples of research efforts which are appropriate
under this priority area include, but are not limited to: (a) engineering
controls: these could encompass the development and evaluation of new, or the
application and evaluation of existing, equipment or devices which could
prevent childhood agricultural injuries, such as ensuring that agricultural
structures have proper barriers and warnings, developing and evaluating play
area designs to reduce child exposures to hazards, and developing and
evaluating, or evaluating existing, sensor technology to notify operators or
automatically shut down machines when children are in harms way and/or (b)
administrative controls: these could encompass the evaluation of the impact
of changes in work practices, such as limiting the type of work a youth does
[e.g., not allowing youth under 16 to drive tractors or evaluation of the
impact of the North American Guidelines for Children's Agricultural Tasks
(NAGCATs)], modification of work periods, (such as limiting the amount of
time a youth works), limiting the exposure of the youth (ensuring equipment
in the work environment is properly shielded or limiting loads lifted or
carried), and the type and amount of training and supervision given to the
young worker.
o Develop and Evaluate Incentives which Encourage Adults to Adopt Injury
Control Strategies to Protect Youth.
Adults are the primary agent for determining the safety of youth on farms.
Understanding the factors which cause adults to adopt protective activities
for youth on their farms or cease activities which increase risk for youth
are important to prevention efforts. Identifying the type, kind and
magnitude of incentives which lead adults to adopt injury control strategies
can lead to reduced risk for youth who live on, work on, or visit farms.
Examples of research efforts which are appropriate under this priority area
include, but are not limited to: (a) incentives needed by adults to adopt
methods to reduce or eliminate the risk of injury from agricultural
production, such as implementing affordable and accessible childcare which is
readily available to farm families, or (b) incentives required to establish
safe play and recreation areas for youth on farms, or c) for farms that are
using young workers, incentives which are successful in getting adults to use
model programs for training and supervising young agricultural workers to
reduce the risk of injury.
o Identify the Economic and/or Social Consequences of Youth Working on Farms.
Data on positive as well as negative outcomes of youth's involvement in
agriculture are needed to develop a balanced response to protecting children.
Examples of research efforts which are appropriate under this priority area
include, but are not limited to: (a) studies to estimate the societal and
economic costs and consequences associated with childhood agricultural
injury; (b) assessments of short- and long-term disability from injuries; (c)
assessment of short- and long-term psychosocial outcomes (positive and/or
negative) related to children's and adolescents' participation in different
types of agricultural work; (d) actual costs to protect youth from hazards on
the farm; (e) physical assessments of children and adolescents who have been
exposed to agricultural hazards such as agricultural chemicals, organic
dusts, toxic gases, nitrates, volatile organic compounds, oils and solvents;
and, (f) studies of the impact of noise, vibration, cumulative trauma, and
other work or environment-induced health hazards on children and adolescents
working on farms.
Useful Reference
National Committee for Childhood Agricultural Injury Prevention. Children and
Agriculture: Opportunities for Safety and Health. Marshfield, WI: Marshfield
Clinic. 1996,
http://research.marshfieldclinic.org/children/action/title.htm.
Lee, B. Gallagher, S. Marlenga, B. and Hard, D. (Eds.). 2002. Childhood
Agricultural Injury Prevention: Progress Report and Updated National Action
Plan for the 2001 Summit. Marshfield, WI: Marshfield Clinic.
http://www.marshfieldclinic.org/research/children/childrensReport/.
MECHANISM OF SUPPORT
This RFA will use NIOSH individual research project grant (R01) award
mechanism. As an applicant you will be solely responsible for planning,
directing, and executing the proposed project. This RFA is a one-time
solicitation. The anticipated award date is August 1, 2003 and will be made
for a 12-month budget period. Continuation awards within the project period
will be made on the basis of satisfactory progress and availability of funds.
Applications that are not funded in the competition described in this RFA may
be submitted as NEW investigator-initiated applications using the standard
receipt dates for NEW applications described in the instructions on the PHS
398 application.
This RFA uses just in time concepts. It also uses the modular budget format,
rather than the detailed budget format (see
https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular format. This program does not require cost sharing.
FUNDS AVAILABLE
NIOSH intends to commit approximately one million ($ 1,000,000)in fiscal year
(FY) 2003 to fund approximately four to six new and/or competitive
continuation grants in response to this RFA. An applicant may request a
project period of up to 3 years and a budget for direct costs of up to
$250,000 per year. Because the nature and scope of the proposed research
will vary from application to application, it is anticipated that the size
and duration of each award will also vary. Although the financial plans of
NIOSH provide support for this program, awards pursuant to this RFA are
contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.
Use of Funds
Applicants should include in their budget travel funds for one trip per year
for an annual meeting with NIOSH scientists to be held in Morgantown, West
Virginia. The purpose of this meeting is to provide an opportunity for the
exchange and dissemination of scientific information.
ELIGIBLE INSTITUTIONS
You may submit (an) application (s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories.
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic and foreign
o Faith-based or community-based organizations
o Indian Tribes, Tribal Governments, Colleges, and/or Organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIOSH programs.
Note: Title 2 United States Code section 1611 states that an organization
described in section 501(c)(4) of the Internal Revenue Code that engages in
lobbying activities is not eligible to receive Federal funds constituting an
award, grant, or loan.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues. This RFA and other CDC Announcements can be found on the CDC
HomePage at http://www.cdc.gov/, under the Funding Section (see Grants
and Cooperative Agreements scroll down to Occupational Safety and Health).
This RFA can also be found on the NIOSH HomePage
http://www.cdc.gov/niosh/homepage.html, under Extramural Programs, Current
Funding Opportunities.
Direct your questions about scientific/research issues to:
Adele Childress, Ph.D., MSPH
Scientific Program Administrator
Office of Extramural Programs
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 24, Room 1427, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2509
FAX: (404) 498-2571
Email: ahc0@cdc.gov
Direct your questions about NIOSH agricultural research program issues to:
Stephen Olenchock, Ph.D.
Agriculture Coordinator
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1095 Willowdale Road, P04/1119
Morgantown, WV 26505-2888
Telephone: (304) 285-6271
FAX: (304) 285-6075
Email: solenchock@cdc.gov
Direct your questions about peer review issues to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone: 304-285-5979
FAX: 304-285-6147
Email: pmajor@cdc.gov
Direct inquiries about financial or grants management matters to:
Larry Guess
Acting Chief
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-03-003
Telephone: (412) 386-6826
Email: lguesws@cdc.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of an application, the information that it contains is
used to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of
this document and should be sent to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
FAX: 304-285-6147
Email: pmajor@cdc.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone 301/710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTAL INSTRUCTIONS:
If the proposed project involves organizations or persons other than those
affiliated with the applicant organization, letters of support and/or
cooperation must be included.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular grant format. The modular grant format simplifies the preparation of
the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001) at
https://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
https://grants.nih.gov/grants/funding/phs398/labels.pdf
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed photocopies, in
one package to:
Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must also
be sent to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
FAX: 304-285-6147
Email: pmajor@cdc.gov
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of the RFA. If an application is received
after that date, it will be returned to the applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Review (CSR) and NIOSH will not accept any
application in response to this RFA that is essentially the same as one
currently pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application, originally
submitted as an investigator-initiated application, is to be submitted in
response to this RFA, it is to be prepared as a NEW application. That is the
application for the RFA must not include an Introduction describing the
changes and improvements made, and the text must not be marked to indicate
the changes. While the investigator may still benefit from the previous
review, the RFA application is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NIOSH. Incomplete applications will be returned to the
applicant without further consideration. And, if the application is not
responsive to the RFA, NIOSH staff may contact the applicant to determine
whether to return the application to the applicant or submit it for review in
competition with unsolicited applications at the next appropriate NIH review
cycle.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by a scientific review group convened by
NIOSH in accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o Receive a written critique.
o Undergo a process in which only those applicants deemed to have the highest
scientific or technical merit, generally the top half of the applications
under review, will be discussed and assigned a priority score.
o Receive a second level of review by the NIOSH Secondary Review Committee.
REVIEW CRITERIA
Review Criteria
The criteria that NIOSH will use to review applications for scientific merit
and for meeting program objectives are provided below. In the written
comments, reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will
have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these criteria
in assigning the application's overall score, weighting them as appropriate
for each application. The application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example it may propose to carry out
important work that by its nature is not innovative but essential to move a
field forward.
o SIGNIFICANCE: Does this study address an important problem related to the
research areas outlined in this announcement? If the aims of the application
are achieved, how will scientific knowledge be advanced? Define the
significance of the proposed research to the prioritization, development, or
implementation of intervention efforts. What will be the effect of these
studies on the concepts or methods that drive this field?
o APPROACH: Are the conceptual framework, design (including composition of
study population), methods, and analyses adequately developed, well-
integrated, and appropriate to the aims of the project? How will the
proposed research meet the goals of the program to prioritize, develop, or
implement intervention efforts? Does the applicant acknowledge potential
problem areas and consider alternative approaches?
o INNOVATION: Does the project employ novel concepts, approaches, or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
o INVESTIGATOR: Is the investigator appropriately trained and well-suited to
carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers, if any?
o ENVIRONMENT: Does the scientific environment in which the work will be
performed contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific environment
or employ useful collaborative arrangements? Is there documentation of
cooperation from stakeholders in the project, where applicable? Is there
evidence of institutional support and availability of resources necessary to
perform the project?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
o PROTECTIONS OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
o INCLUSIONS OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subject from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations,
below).
o CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are
to be used in the project, the five items described under Section f of the
PHS 398 research grant application instructions (rev. 5/2001 will be
assessed).
ADDITIONAL CONSIDERATIONS
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
o Availability of special opportunities for furthering research programs
through the use of unusual talent resources, populations, or environmental
conditions in other countries which are not readily available in the United
States or which provide augmentation of existing U.S. resources.
Programmatic Review Criteria
o Magnitude of the problem in terms of numbers of children affected.
o Severity of the disease or injury in the population.
o Likelihood of developing applied technical knowledge for the prevention of
childhood agricultural safety and health hazards on a national or regional
basis.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: April 18, 2003
Application Receipt Date: May 23, 2003
Earliest Anticipated Start Date: August 1, 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit
o Availability of funds
o Programmatic priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the CDC that women and members of minority groups and their sub-populations
must be included in all CDC-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
For Inclusion of Women and Minorities as Subjects in Clinical Research, -
amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are
available at https://grants.nih.gov/grants/funding/women_min/women_min.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles and
responsibilities of CDC staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b)investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998. This policy will be followed by NIOSH
for this announcement.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects" that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
HUMAN SUBJECT REGUIREMENTS: If the proposed project involves research on
human subjects, the applicant must comply with the Department of Health and
Human Services (DHHS) Regulations (Title 45 Code of Federal Regulations Part
46) regarding the protection of human research subjects. All awardees of CDC
grants and cooperative agreements and their performances sites engaged in
human subjects research must file an assurance of compliance with the
regulations and have continuing reviews of the research protocol by
appropriate institutional review boards.
In order to obtain a federal-wide Assurance (FWA) of Protection for Human
Subjects, the applicant must complete an on-line application at the Office
for Human Research Protections (OHRP) website or write to the OHRP for an
application. OHRP will verify that the signatory official and the Human
Subjects Protections Administrator have completed the OHRP Assurance
Training/Education Module before approving the FWA. Existing Multiple
Project Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single
Project Assurances (SPAs) remain in full effect until they expire or until
December 31, 2003, whichever comes first.
To obtain a FWA contact the OHRP at: http://www.hhs.gov/ohrp/assurances/assurances_index.html
or write to:
Office for Human Research Protections (OHRP)
Department of Health and Human Services
6100 Executive Boulevard, Suite 3B01, MSC 7501
Rockville, Maryland 20892-7507
(Note: For Express or Hand Delivered Mail, Use Zip Code 20852)
Note: In addition to other applicable committees, Indian Health Service (IHS)
institutional review committees must also review the project if any component
of IHS will be involved with or will support the research. If any American
Indian community is involved, its tribal government must also approve the
applicable portion of that project.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: (if
applicable) NIH policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for research
involving human subjects. You will find this policy announcement in the NIH
Guide for Grants and Contracts Announcement, dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
ANIMAL SUBJECTS REQUIREMENTS: If the proposed project involves research on
animal subjects, compliance with the "PHS Policy on Humane Care and Use of
Laboratory Animals by Awardee Institutions" is required. An applicant (as
well as each subcontractor or cooperating institution that has immediate
responsibility for animal subjects) proposing to use vertebrate animals in
CDC-supported activities must file (or have on file) the Animal Welfare
Assurance with the Office of Laboratory Animal Welfare (OLAW) at the National
Institutes of Health. The applicant must provide in the application the
assurance of compliance number and evidence of review and approval (including
the date of the most recent approval) by the Institutional Care and Use
Committee (IACUC). Web page https://grants.nih.gov/grants/olaw/olaw.htm
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIOSH funding must be self-contained within specified page
limitations. Unless otherwise specified in a NIOSH solicitation, internet
addresses (URLs) should not be used to provide information necessary to the
review because reviewers are under no obligation to view the Internet sites.
Furthermore, we caution reviewers that their anonymity may be compromised
when they directly access an Internet site.
LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use
of Health and Human Services (DHHS) funds for lobbying of Federal or State
legislative bodies. Under the provisions of 31 U.S.C. Section 1352,
recipients (and their subtier contractors) are prohibited from using
appropriated Federal funds (other than profits from a Federal contract) for
lobbying congress or any Federal agency in connection with the award of a
particular contract, grant, cooperative agreement, or loan. This includes
grants/cooperative agreements that, in whole or in part, involve conferences
for which Federal funds cannot be used directly or indirectly to encourage
participants to lobby or to instruct participants on how to lobby.
In addition, no part of the Centers for Disease Control and Prevention (CDC)
appropriated funds shall be used, other than for normal and recognized
executive-legislative relationships, for publicity or propaganda purposes,
for the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to support or
defeat legislation pending before the Congress or any State or local
legislature, except in presentation to the Congress or any State or local
legislature itself. No part of the appropriated funds shall be used to pay
the salary or expenses of any grant or contract recipient, or agent acting
for such recipient, related to any activity designed to influence legislation
or appropriations pending before the Congress or any State or local
legislature.
Any activity designed to influence action in regard to a particular piece of
pending legislation would be considered "lobbying." That is lobbying for or
against pending legislation, as well as indirect or "grass roots: lobbying
efforts by award recipients that are directed at inducing members of the
public to contact their elected representatives at the Federal or State
levels to urge support of, or opposition to, pending legislative proposals is
prohibited. As a matter of policy, CDC extends the prohibitions to lobbying
with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the
legislative branch, or to prohibit educational efforts pertaining to public
health. Clearly there are circumstances when it is advisable and permissible
to provide information to the legislative branch in order to foster
implementation of prevention strategies to promote public health. However,
it would not be permissible to influence, directly or indirectly, a specific
piece of pending legislation.
It remains permissible to use CDC funds to engage in activity to enhance
prevention; collect and analyze data; publish and disseminate results of
research and surveillance data; implement prevention strategies; conduct
community outreach services; provide leadership and training; and foster safe
and healthful environments.
Recipients of CDC grants and cooperative agreements need to be careful to
prevent CDC funds from being used to influence or promote pending
legislation. With respect to conferences, public events, publication, and
"grassroots" activities that relate to specific legislation, recipients of
CDC funds should give attention to isolating and separating the appropriate
use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC
funds to be careful not to give the appearance that CDC funds are being used
to carry out activities in a manner that is prohibited under Federal law.
SMALL, MINORITY, AND WOMEN-OWNED BUSINESS: It is a national policy to place a
fair share of purchases with small, minority and women-owned business firms.
The Department of Health and Human Services is strongly committed to the
objective of this policy and encourages all recipients of its grants and
cooperative agreements to take affirmative steps to ensure such fairness. In
particular, recipients should:
1. Place small, minority, women-owned business firms on bidders mailing lists.
2. Solicit these firms whenever they are potential sources of supplies,
equipment, construction, or services.
3. Where feasible, divide total requirements into smaller needs, and set
delivery schedules that will encourage participation by these firms.
4. Use the assistance of the Minority Business Development Agency of the
Department of Commerce, the Office of Small and Disadvantaged Business
Utilization, DHHS, and similar state and local offices.
RESEARCH INTEGRITY: The signature of the institution official on the face
page of the application submitted under this Program Announcement is
certifying compliance with the Department of Health and Human Services (DHHS)
regulations in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS
Awardee and Applicant Institutions for Dealing with and Reporting Possible
Misconduct in Science."
The regulation places several requirements on institutions receiving or
applying for funds under the PHS Act that are monitored by the DHHS Office of
Research Integrity's (ORI) Assurance Program.
For examples:
Section 50.103(a) of the regulation states: "Each institution that applies
for or receives assistance under the Act for any project or program which
involves the conduct of biomedical or behavioral research must have an
assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has
established an administrative process, that meets the requirements of this
subpart, for reviewing, investigating, and reporting allegations of
misconduct in science in connection with PHS-sponsored biomedical and
behavioral research conducted at the applicant institution or sponsored by
the applicant; and (2) Will comply with its own administrative process and
the requirements of this Subpart."
Section 50.103(b) of the regulation states that: "an applicant or recipient
institution shall make an annual submission to the [ORI] as follows: (1) The
institution's assurance shall be submitted to the [ORI], on a form prescribed
by the Secretary,...and updated annually thereafter...(2) An institution
shall submit, along with its annual assurance, such aggregate information on
allegations, inquiries, and investigations as the Secretary may prescribe."
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This RFA is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301(a) [42 U.S.C. 241(a)], the Occupational Safety and Health Act of 1970,
Section 20(a) [29 U.S.C. 669(a)] [number: 93.956, Agricultural Health and
Safety Program of the National Institute for Occupational Safety and Health
(NIOSH)], and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.